MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD VERSAPORT PLUS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	NB12STF
Medical Device Problem Codes	Detachment Of Device Component (1104); Packaging Problem (3007); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Tissue Damage (2104); Radiation Exposure, Unintended (3164); No Code Available (3191)
Date of Event	07/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: during a laparoscopic procedure, the device the obturator/ trocar broke.Procedure converted to open procedure.A device once it was pushed through the patient's abdomen the white tip that retracts out of the sheath while pressure was being exerted snapped off.This white piece of plastic has not been able to be recovered after an x-ray and further surgery was needed to open patient to try and find the object.The surgical time extended 30 minutes or more due to the product problem.Both times the plastic has not be located.There was permanent tissue damage as a result of this problem.The incision was extended more than 1 inch (2.54 cm).No patient injury has been noted.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of five devices.The visual inspection of the returned product noted that on device one there were gouges at the distal end of the trocar.The tip of the white retractable sheath was broken off.The visual inspection of the other four devices noted that they were received intact in the appropriate packaging.Pmv performed functional testing of device one: the device passed an air leak test.Pmv performed functional testing of the other four devices; the devices were removed from their packaging, they passed an air leak test and all other components functioned properly.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Replication of the gouges at the distal end of the trocar and the broken tip of the white retractable sheath may occur when the devices are mishandled during clinical application.Based on the evidence available the reported condition was confirmed.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VERSAPORT PLUS
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 6784560
• Report Number: 9612501-2017-05928
• Device Sequence Number: 1491710
• Product Code: GCJ
• UDI-Device Identifier: 10884521076495
• UDI-Public: 10884521076495
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081169
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: NB12STF
• Device Catalogue Number: NB12STF
• Device Lot Number: J6J2578X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Initial Date Received by Manufacturer: 07/12/2017
• Supplement Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 09/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention